Noninferiority comparison of electromagnetic navigation-guided versus computed tomography-guided percutaneous localization of multiple small pulmonary nodules: a prospective randomized clinical trial.

IF 2.5 3区医学 Q3 ONCOLOGY World Journal of Surgical Oncology Pub Date : 2024-11-30 DOI:10.1186/s12957-024-03606-z

Hongliang Hui, Haoran Miao, Fan Qiu, Huaming Li, Yangui Lin, Yiqian Zhang, Bo Jiang

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Abstract

Background: Accurate preoperative localization is a challenge in thoracoscopic surgery for multiple pulmonary nodules. In this study, we aimed to assess the accuracy and feasibility of electromagnetic navigation (EN)-guided percutaneous localization.

Methods: We enrolled 50 patients with multiple pulmonary nodules for EN-guided (EN group) or CT-guided (CT group) localization. The primary outcome was the localization accuracy, and the primary analysis was to assess the noninferiority (noninferiority margin of 5 mm) of EN-induced localization deviation compared with that of CT-induced deviation. The secondary outcomes included the procedural duration, anxiety score, and incidence of complications.

Results: Among the 50 patients randomized to the EN- and CT-guided groups, 24 patients (53 nodules) underwent EN-guided preoperative marking, and 25 patients (54 nodules) underwent CT-guided preoperative marking. The demographic, clinical, and radiological characteristics did not differ significantly between the groups (P > 0.05). Among these patients, the EN group was noninferior in terms of localization deviation compared with the CT group (9.0 [6.5] vs. 7.5 [6.0] mm; P = 0.33; absolute difference 0.9 [95% CI] 0.03-1.77]). Furthermore, the procedural duration was 16.3 (4.2) minutes for the EN group and 22.3 (8.2) minutes for the CT group (P = 0.002). Additionally, the EN group exhibited significant improvements compared with the CT group on the basis of the Amsterdam Preoperative Anxiety and Information Scale, particularly in relation to the S and C subscales' cumulative scores.

Conclusions: EN was found to be noninferior to CT in terms of localization accuracy, as it significantly decreased the procedural duration and relieved psychological stress for patients who underwent simultaneous surgery for multiple pulmonary nodules.

Clinical trial registration: Chinese Clinical Trial Registry Identifier: ChiCTR2200056734.

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一项前瞻性随机临床试验：电磁导航引导与计算机断层扫描引导下经皮定位多发小肺结节的非劣效性比较。

背景：胸腔镜手术治疗多发肺结节时，术前准确定位是一个挑战。在本研究中，我们旨在评估电磁导航（EN）引导下经皮定位的准确性和可行性。方法：选取50例多发性肺结节患者进行EN引导（EN组）或CT引导（CT组）定位。主要结果是定位准确性，主要分析是评估en诱导的定位偏差与ct诱导的定位偏差的非劣效性（非劣效裕度为5 mm）。次要结果包括手术时间、焦虑评分和并发症发生率。结果：50例患者随机分为EN引导组和ct引导组，24例患者（53个结节）行EN引导术前标记，25例患者（54个结节）行ct引导术前标记。两组患者的人口学、临床和放射学特征无显著差异（P < 0.05）。在这些患者中，与CT组相比，EN组在定位偏差方面并不逊色(9.0[6.5]比7.5 [6.0]mm；p = 0.33；绝对差异0.9 [95% CI] 0.03-1.77])。此外，EN组的手术时间为16.3（4.2）分钟，CT组为22.3（8.2）分钟（P = 0.002）。此外，在阿姆斯特丹术前焦虑和信息量表的基础上，与CT组相比，EN组表现出显著的改善，特别是在S和C亚量表的累积得分方面。结论：EN在定位准确性上不逊于CT，对于同时行多肺结节手术的患者，EN可显著缩短手术时间，减轻心理压力。临床试验注册：中文临床试验注册号：ChiCTR2200056734。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

World Journal of Surgical Oncology ONCOLOGY-SURGERY

CiteScore

4.70

自引率

15.60%

发文量

362

审稿时长

3 months

期刊介绍： World Journal of Surgical Oncology publishes articles related to surgical oncology and its allied subjects, such as epidemiology, cancer research, biomarkers, prevention, pathology, radiology, cancer treatment, clinical trials, multimodality treatment and molecular biology. Emphasis is placed on original research articles. The journal also publishes significant clinical case reports, as well as balanced and timely reviews on selected topics. Oncology is a multidisciplinary super-speciality of which surgical oncology forms an integral component, especially with solid tumors. Surgical oncologists around the world are involved in research extending from detecting the mechanisms underlying the causation of cancer, to its treatment and prevention. The role of a surgical oncologist extends across the whole continuum of care. With continued developments in diagnosis and treatment, the role of a surgical oncologist is ever-changing. Hence, World Journal of Surgical Oncology aims to keep readers abreast with latest developments that will ultimately influence the work of surgical oncologists.